Ingrown Toenails : Surgery Only Versus Surgery + Chemical Cauterization With TCA
Etude Comparative Multicentrique Prospective évaluant la Prise en Charge Chirurgicale associée à Une cautérisation Chimique Par Acide TCA Par Rapport à la Prise en Charge Chirurgicale Standard Dans le Traitement de l'Ongle incarné
Ingrown toenail is a very common disease in the general population that touches young adults. There are lots of treatments from local care of pedicure to surgery with matricectomy. Gold standard of symptomatic and painful ingrown toenail is the simple surgery with matricectomy and with suture or directed healing pad.
For many years chemical cauterisation with phenolic acid is used, a method with very few relapses and with a more simple pad. However, because of a lack of information about this phenolic acid, the pharmaceutical laboratory withdrew it from the market.
The new method to replace phenolic acid is trichloroacetic acid, used mainly in cosmetics for peeling. This method was already compared to phenolic acid and showed equal results with fewer laps of application and a low cost. The comparison between acid trichloroacetic method and the gold standard surgery was never done and will be the goal of this study.
It's an open, non randomised, comparative, multicentric (2 centers) study with two groups : common surgery and surgery with chemical cauterisation For this study the investigators will compare between the two groups : gain of quality of life at one month after surgery, difference of pain between before, one week and one month after surgery, the occurrence of adverse events and number of relapses at one year.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Normandie
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Caen, Normandie, Frankrike, 14000
- Rekrytering
- Centre Hospitalier Universitaire de Caen
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Kontakt:
- Secretariat DRCI
- Telefonnummer: 0231065781
- E-post: drci-secretariat@chu-caen.fr
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Saint-Lô, Normandie, Frankrike, 50000
- Rekrytering
- Centre hospitalier Mémorial France Etats Unis
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Kontakt:
- Unité de recherche clinique
- Telefonnummer: 0233067446
- E-post: gaelle.lambert@ch-stlo.fr
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Clinical diagnosis of ingrown toenail
- Patient informed and with signed informed consent
Exclusion Criteria:
- Medical history of ingrown toenail on the concerned nail
- Other nail disease
- Pregnancy
- Allergy to local anesthetic or to trichloroacetic acid
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Dermatologic intervention
Surgery with chemical cauterisation TCA
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Removal of the ingrown lateral part of the toenail and chemical cauterisation
|
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Aktiv komparator: Orthopedic intervention
Only surgery
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Removal of the ingrown lateral part of the toenail with directed Healing pad
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Relapses
Tidsram: one year
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Relapses of ingrown toenail on the operated nail
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one year
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gain of quality of life
Tidsram: Baseline and one month after the surgery
|
Quality of life will be measured with the Dermatology Life Quality Index adapted to the nail, there are 9 questions that will be filled by the patient. Each questions have 4 possibilities to 0 (no problem) to 3(hugely). So the score go to 0 to 27. Questions are, on last 7 days :
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Baseline and one month after the surgery
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|
Complications
Tidsram: At one week and one month after surgery
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Bleeding, infection, pain
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At one week and one month after surgery
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|
Pain on the nail
Tidsram: Baseline, one week and one month after surgery
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Pain report on a numeric scale of pain to 0 (no pain) to 10(worst pain possible)
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Baseline, one week and one month after surgery
|
|
Time before restart sport
Tidsram: Restart sport at one month yes/no
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Time to recover a normal physical activity
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Restart sport at one month yes/no
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Pr DOMPMARTIN ANNE, CHU CAEN
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20-090
Plan för individuella deltagardata (IPD)
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